Mental Skills Training for Athletes After ACL Reconstruction

(ROAR 3 Trial)

AM
DM
Overseen ByDai M Sugimoto, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary aim is to determine if MST will improve coping skills in young athletes returning to sport after ACLR as measured by ACSI-28. Participants will undergo MST led by masters-level mental skills specialist pre-operatively, 3 months, 6 months, and 9 months post-operatively. Power analysis suggested at least 52 pairs are needed (α=0.05, β=0.80). There will be 65 patients enrolled in both the MST group and the control group (no MST) for a total of 130 patients. This will allow for a 4-point difference in ACSI and a 20% dropout rate.

The secondary aim is to determine if MST will improve psychological readiness and athletic identity as well as decrease psychological stress, anxiety, depression, and PTSD symptoms of young athletes returning to sport after ACLR as measured by ACL-RSI, AIMS, PROMIS-PSE, GAD-7, PHQ-9, and CRIES, respectively.

Who Is on the Research Team?

MD

Matthew D Milewski, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with a complete ACL tear.
I am having ACL reconstruction at Boston Children's Hospital with a study surgeon.
I am between 8 and 25 years old.
See 1 more

Exclusion Criteria

Previous ACL tear
Non-English speaking patient/family
Lack of intention to return to sports/sporting activities
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Mental Skills Training (MST)

Participants undergo MST led by masters-level mental skills specialist before surgery

1-2 weeks
1 visit (in-person)

Post-operative MST and Monitoring

Participants receive MST at 3, 6, and 9 months post-operatively and are monitored for psychological readiness and coping skills

9 months
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1 year and 2 years post-operatively

15 months
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Mental Skills Training (MST)

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Mental Skills Training (MST) CohortExperimental Treatment1 Intervention
Group II: Non-MST CohortActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials
801
Recruited
5,584,000+